Parenteral solutions broadly cover fluid replacement, electrolyte replacement and are vehicles for drug medication. Solutions include blood plasma, platelets, red cells, kidney dialysis solutions, saline solutions and nutritional products. These solutions were initially bottled in glass, however, with the introduction of the collapsible parenteral solution bag some years ago, airborne contamination was significantly reduced since the flexible bags empty without outside air entering the system.
The general requirements of a resin used in the manufacture of the parenteral solution bags include flexibility, clarity, toughness at low temperatures, heat-sealability, good processability, moisture vapor permeability resistance and ability to be sterilized. The industry is presently employing a highly plasticized PVC film for this purpose. Although this resin does meet most of the requirements, a material is preferred that has little or no plasticizer. Also, the PVC film is not very resistant to moisture vapor permeability, and consequently, the continuing loss of moisture of the parenteral solutions reduces their storage life considerably. Therefore, it is required that the bag be sealed within an overpouch made from a film resin designed to have a low water vapor transmission rate (WVTR).
In the manufacture of molded specialty bottles and containers, many of the above-mentioned properties are also desired although other properties might need to be different e.g. the degree of stiffness might be varied from one application to another.
It is therefore an object of the present invention to provide a resin composition which is adapted for processing into heat-sterilizable, flexible films.
It is another object of the invention to provide a resin composition adaptable for the manufacture of flexible containers.
It is a further object to provide a composition useful in the manufacture of tear tab bottles.
It is an object of the present invention to provide a film useful in the manufacture of sterilizable, collapsible bags for direct and for indirect containment of parenteral solutions.